Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Astral · 1 trial · 3 indications
Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP
| Arm | Type | Description |
|---|---|---|
| iVAPS with AutoEPAP | EXPERIMENTAL | This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with AutoEPAP on the first night, and on iVAPS with manual EPAP on the second night. |
| iVAPS with manual EPAP | ACTIVE_COMPARATOR | This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with manual EPAP on the first night, and on iVAPS with AutoEPAP on the second night. |
| Name | Type | Description |
|---|---|---|
| Astral | DEVICE | Astral ventilator |
Inclusion criteria for the study are: 1. Participant has ability to provide written informed consent 2. Participants aged ≥18 years old 3. Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg) 4. Pa...
Astral is a medical device used for upper airway obstruction, respiratory insufficiency, and respiratory failure. It is a ventilator system developed by ResMed Inc. that provides respiratory support to patients with these conditions. The device is currently in Phase 3 clinical development.
Astral is developed by ResMed Inc., a company traded on the stock exchange under the ticker RMD. ResMed is a medical device company focused on respiratory care, and Astral is one of its products for respiratory support.
Astral is in Phase 3 clinical development. It has completed one Phase 3 clinical trial, which was an active-controlled study. The trial has been completed, and the device is not yet approved by the FDA.
Astral has one completed clinical trial with the identifier NCT02683772, titled 'Astral VAPS AutoEPAP Clinical Trial.' This Phase 3 trial enrolled 42 participants in the United States and studied the device for upper airway obstruction, respiratory insufficiency, and respiratory failure.
Astral is not FDA approved. It is an investigational device that is still in clinical development. The Phase 3 clinical trial for Astral has been completed, but the device has not yet received regulatory approval.